ADVIA 1800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-05-31 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[76243904] The customer contacted a siemens customer care center (ccc) specialist. The ccc reviewed the data supplied. The customer's quality control (qc) was in range at the time of the event. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse realigned all probes to the center of cuvette. The cse checked probe height alignments and realigned sample probe and sample dilution probe. The cse verified mixer alignments were within specifications. The cse verified dilution washer and reaction tray washer were within specification. The cse washed reaction tray washer with probe wash. The cse cleaned all probes and mixer rods. The customer performed a precision test and ran qc, resulting within range and specification. No further issues were found. The cause of the discordant, falsely depressed c-reactive protein result is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10


[76243905] A discordant, falsely depressed c-reactive protein result was obtained on a patient sample on an advia 1800 instrument. The initial result was released to the physician(s), which was questioned. The customer repeated the same sample on the same advia 1800 instrument, resulting higher. The customer issued a corrected report to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed c-reactive protein result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2432235-2017-00344
MDR Report Key6600186
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-05-31
Date of Report2017-05-31
Date of Event2017-04-23
Date Mfgr Received2017-05-04
Date Added to Maude2017-05-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTIMOTHY RICE
Manufacturer Street511 BENEDICT AVE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242406
Manufacturer G1JEOL LTD
Manufacturer StreetREGISTRATION #: 3003637681 3-1-2 MUSASHINO AKISHIMA
Manufacturer CityTOKYO, 196-8558
Manufacturer CountryJA
Manufacturer Postal Code196-8558
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameADVIA 1800
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeDCN
Date Received2017-05-31
Model NumberADVIA 1800
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No0
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address511 BENEDICT AVE. TARRYTOWN NY 10591 US 10591

Device Sequence Number: 1

Brand NameADVIA 1800
Generic NameCLINICAL CHEMISTRY ANALYZER
Product CodeJJE
Date Received2017-05-31
Model NumberADVIA 1800
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address511 BENEDICT AVE. TARRYTOWN NY 10591 US 10591


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-31

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